10th Annual BioProcess International European Summit

2-3 April 2014, Clarion Congress Hotel, Prague, Czech Republic

Events

Visit us at the 10th BioProcess International European Summit

April 2-3, 2014

We are pleased to announce that Tara A. Nestor MEngSc, MBA, Associate Director Product Robustness, Bristol-Myers Squibb will be presenting on our behalf along with Justin Neway, Ph.D., Vice President and Senior Fellow, Accelrys ADQM

Details of all presentations can be found below:

Presentation Title

The Global Manufacturing Process Robustness Program at Bristol-Myers Squibb: Progress & Expectations

Date & Time Wednesday 2nd April, 15.30
Presenter Tara A. Nestor, Bristol-Myers Squibb & Justin Neway, Accelrys ADQM


Abstract
The most important business and regulatory benefits expected from the FDA and ICH Quality by Design (QbD) initiative is more robust manufacturing processes with reduced variability and increased predictability.  These translate to reduced risks to patient safety and lower supply chain costs.  Implementing a Process Robustness program entails implementing technology solutions that enable access to and use of process data for trending, automated alerts and improved process understanding.  This presentation will review the approach that Bristol-Myers Squibb has taken to Process Robustness as well as some of the challenges and successes along the way.

Participants will hear about:

  • Access to process and quality data stored in electronic and paper systems
  • Improving data analysis and understanding process variability
  • Defining the essential elements of a global Process Robustness program
  • Challenges to implementing Process Robustness across the global network
  • Business benefits and expectations for future expansion

Conference Website

We look forward to seeing you in Prague!

 

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